Topic archive
MedTech Current publications and recall entries tagged Dental & Ophthalmic Devices.
The non-binding MHLW guidance distinguishes non-clinical equivalence evidence from the human oral clinical evaluation generally needed for implant-related use, while preserving justified exceptions.
This is a labeling and technique-focused correction rather than a product-removal event, but the potential consequences involve direct ophthalmic tissue injury during cataract procedures. It is a useful reminder that field corrections may address device-design interaction with user technique even when products remain available for use under clarified instructions.
FDA has issued two final 510(k) guidances covering dental composite resin devices and dental curing lights, replacing guidance documents from 2005 and 2006. The final versions update FDA's recommendations for device description, performance testing, and labeling, including clarified shelf-life testing for composite resins and revised radiant-power testing expectations for curing lights.